Biaxial Microincision Cataract Surgery Technique

• Conditions: Cataract Senile
• Interventions: Procedure: BiMICS

• Registration Number: NCT03793101
• Lead Sponsor: Eyemed Centrum Okulistyczne

Brief Summary

To analyze and compare visual results, keratometry, SIA and HOAs outcomes of biaxial microincision cataract surgery in elderly population, including diabetic and non-diabetic patients.

Detailed Description

Modern trends in cataract surgery is the bimanual MICS technique. MICS significant development for 15 years gives possibility to implant the intraocular lens by 1.4mm incision. This is not only a change in surgery technique, but it is a significant progress in safety and quality post-operative results. Bimanual cataract MICS technique gives the opportunity to reduce width of the corneal incision more than 40% comparing to the standard coaxial cataract surgery by use dedicated MICS IOL's. This allows to perform less traumatic surgery and provides the opportunity for fast visual rehabilitation from the first week after cataract surgery. The possibility of using multifocal and toric intraocular lenses in MICS technique fully meet the requirements of modern refractive intraocular surgery.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-12-12
• Study First Submitted: 2018-12-29
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-03
• Last Update Submitted: 2019-01-03
• Study First Posted: 2019-01-04
• Last Update Posted: 2019-01-04
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Clinical diagnose of senile cataract.

Exclusion Criteria

1. Eye trauma in anamnesis.
2. Eye surgery in anamnesis.
3. Corneal surgery in anamnesis.
4. Corneal irregular astigmatism.
5. Corneal ectasia.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BiMICS 1.8	BiMICS	Group 1.8 - Patients operated with 1.8 mm BiMICS technique
BiMICS 1.4	BiMICS	Group 1.4 - Patients operated with 1.4 mm BiMICS technique

Primary Outcome Measures

Name	Time	Method
Visual acuity	3 months	Snellen charts, EDTRS charts

Secondary Outcome Measures

Name	Time	Method
Keratometry	3 months	Diopters
Higher Order Aberrations, HOAs	3 months	Micrones
Surgically Induced Astigmatism, SIA	3 months	Diopters
Corneal Incision thickness	3 nmonths	Micrones

Trial Locations

Locations (1)

Eyemed Centrum Okulistyczne; 🇵🇱 Lublin, Poland